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Quality Manual Ver 1.0
Organizational Quality
Policy, Quality System
Procedures, Scope of
Management System,
Roles & Responsibilities.
Quality Management
System Manual Version 1.0
DIGITOUCH TECHNIOLOGIES PVT LTD
BANGALORE
Contents
Introduction & Overview ..................................................................................................... 3
The Firm ...................................................................................................................... 3
Services ...................................................................................................................... 3
Scope of Quality Management System .............................................................................. 5
Scope Statement ......................................................................................................... 5
Services under Scope of the System: .......................................................................... 5
Locations under Scope of the System: ........................................................................ 5
Quality Policy ...................................................................................................................... 5
Quality Objectives .................................................................... Error! Bookmark not defined.
Sales, Marketing, Business Development .................................................................... 7
Delivery ....................................................................................................................... 7
HR ............................................................................................................................... 8
Admin and Facilities .................................................................................................... 8
IT Administration ......................................................................................................... 8
Roles & Responsibilities .................................................................................................. 10
Management Representative ..................................................................................... 11
Organization Chart .................................................................................................... 12
Internal & External Communication ................................................................................. 13
Quality System Procedures ................................................................................................ 1
Internal Audit Procedure .............................................................................................. 1
Control of Records and Documents ............................................................................. 1
Corrective and Preventive Action Procedure ............................................................... 1
Control of Non-conforming products or processes ....................................................... 5
Quality Manual Ver 1.0
Introduction & Overview
The Firm
DIGITOUCH TECHNOLOGIES PRIVATE LIMITED established on 20th September
2013 by Shri.A.SARVAGNA BHATTACHAR , Smt.REVATHI, Shri .S.DILIP
BHATTACHAR and Shri.S.DISHANTH BHATTACHAR as its Share Holders and
Directors.
Services
DIGITOUCH TECHNOLOGIES PRIVATE LIMITED having its Registered office and
works at Bangalore, INDIA . DIGITOUCH TECHNOLOGIES PRIVATE LIMITED with its
brand name as "9Electric" are the Manufacturer , Importer and Exporters of
* Industrial Plugs
* Industrial Socket
* Industrial Connectors
* Interlock Switch with Socket
* Interlock Switch with Socket along with protection of MCB
* Power Socket Distibution Boards in
a. Thermoplastic
b. CRCA Sheet Metal
C. Stainless Steel 304/304L grade.
The office and manufacturing unit has 4200 Sq.Ft area at No.32, Annappoorneswari
Industrial Estate, Doddakallasandra, near Konanakunte Cross, Kanakapura Road,
Bangalore-560062, INDIA.
The company has Designed and Developed the Moulds which are required for the
producing / manufacturing of Thermoplastic Enclosures , Plugs , Sockets, Connectors
as well as all the tools which are required for manufacturing of Enclosure in CRCA Sheet
Metal / Stainless Steel .
The company has a belief in excellence and is dedicated to providing Out standing
superior and cost effective quality products to its customer as Per IEC Specifications . In
regard to the needs of clients special requirements of the Enclosure as per their
Specification the same can be implemented or innovation in new ideas with improved
designed can be manufactured apart from the Regular Manufacturing.
Quality Manual Ver 1.0
Scope of Quality Management System
Scope Statement
ISO 9001:2008
Services under Scope of the System:
Under the brand "9Electric" , DIGITOUCH TECHNOLOGIES PVT LTD are the
Manufacturer , Importer and Exporters of Industrial Plugs , Industrial Socket, Industrial
Connectors , Interlock Switch with Socket , Interlock Switch with Socket along with
protection of MCB, Power Socket Distribution Boards in Thermoplastic / CRCA Sheet
Metal / Stainless Steel 304/304L grade.
Locations under Scope of the System:
No.32, Annappoorneswari Industrial Estate, Doddakallasandra, near Konanakunte
Cross, Kanakapura Road, Bangalore-560062, INDIA.
Quality Policy
DIGITOUCH TECHNOLOGIES PRIVATE LIMITED
will constantly strive to achieve total customer
satisfaction by ensuring the highest levels of
professional quality in all its activities, while diligently
conforming to the accepted ethical parameters of
conducting business and maintaining an environment
of self-evaluation and continuous improvement.
The main Quality Manual is designated as QMS and the other Quality Procedures
and manual is divided into sections & each section addresses the ISO 9001:2008
standard requirement. The Quality Policy of the Company is mentioned in the following :
QUALITY POLICY
Manufacturer, Importers and Exporters in the brand
The policy and object of "9Electric" Company to become itself as the industry leader in
the field of Electrical by providing superior cost effective quality products to its customers
in time . To achieve this we will:
Provide each associate with the training, tools, skills and motivation to produce the high
quality products and services which meet or exceed our customer’s needs.
Empower the work force so that every one is responsible and accountable for achieving
the high quality in a short time of interval.
Main objective is to deliver superior quality and products to customers and the same
emphasis as the financial and productivity aspects of the business
"9Electric" quality management system and the continuous improvement philosophy
that the system encompasses.
Digitouch Technologies Pvt Ltd , Each and every member and the Staff is aware of the
contents of this Quality System relevant to his work processes as per the quality norms
of ISO 9001:2008 . All of them must be working as per the procedures laid down without
any deviations.
Management
DIGITOUCH TECHNOLOGIES PVT LTD
Sales, Marketing, Business Development Conduct customer feedback surveys with all customers
every business quarter and/or on completion of major
project milestone.
Due Date: 31-Sep-2016
Responsibility: Manager - Sales
Increase customer satisfaction by 5% Due Date: 31-Sep-2016
Responsibility: Manager - Sales
Procure repeat business from existing customers of a
value of USD 100,000
Due Date: 31-Sep-2016
Responsibility: Manager - Sales
Add a minimum of 10new clients to existing client base. Due Date: 31-Sep-2016
Responsibility: Manager – Sales
Delivery Decrease time to deliver by 3% Due Date: 31-Sep-2016
Responsibility: Delivery Manager
Record all customer complaints, respond to them within
agreed and resolve customer complaints with agreed.
Due Date: 31-Sep-2016
Responsibility: Delivery Manager
Decrease customer complaints by 5% Due Date: 31-Sep-2016
Responsibility: Delivery Manager
Decrease recurring customer complaints by 20% Due Date: 31-Sep-2016
Responsibility: Delivery Manager
Decrease service/product rejections by 20% Due Date: 31-Sep-2016
Responsibility: Delivery Manager
Decrease re-work by 10% Due Date: 31-Sep-2016
Responsibility: Delivery Manager
HR Increase number of trainings conducted by 30% Due Date: 31-Sep-2016
Responsibility: HR Manager
Improve the ratio between number of candidates offered
to the number of candidates joining by 20%
Due Date: 31-Sep-2016
Responsibility: HR Manager
Record all exit interview. Due Date: 31-Sep-2016
Responsibility: HR Manager
Bring attrition down to 8% Due Date: 31-Sep-2016
Responsibility: HR Manager
Measure employee satisfaction annually and to maintain
it at a minimum of 80%
Due Date: 31-Sep-2016
Responsibility: HR Manager
Admin and Facilities Conduct documented quarterly preventive maintenance
checks on electrical and plumbing networks.
Due Date: 31-Sep-2016
Responsibility: Admin Manager
Maintain updated registers on material in-out. Due Date: 31-Sep-2016
Responsibility: Admin Manager
IT Administration Maintain updated asset register for all IT and Networking
assets.
Due Date: 31-Sep-2016
Responsibility: IT Manager
Record all IT issues, including incidents, service
unavailability etc. and respond and resolve within agreed.
Due Date: 31-Sep-2016
Responsibility: IT Manager
Quality Manual Ver 1.0
Roles & Responsibilities
Cla
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Description
Man
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MR
Lead
Inte
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Au
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or
Qu
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anag
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HR
Man
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Ad
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Pro
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4.0 Documentation, Control of Documents and Records
A
5.0 Management Responsibility A
5.1 Management Commitment A
5.2 Customer Focus
A
5.3 QMS Policy A
5.4. QMS Objectives A
5.5 QMS Responsibility And Authority
A
5.6 Management Review
A
6.0 Resource Management
A
7.0 Product Realization
A
7.1 Product Realization Processes
A
7.2 Customer Related Processes
A
7.3 Design and Development A
7.4 Purchasing Process A
7.5 Control Of Production Provision
A
7.6 Control Of Monitoring And Measuring equipments
A
8.0 Measurement Analysis And Improvement
A
8.1 General
A
8.2.1 Monitoring Of Customer Satisfaction
A
8.2.2 Internal Audits
A
8.2.3 Monitoring And Measurement Of Processes
A
8.2.4 Monitoring And Measurement Of Product
A
8.3 Control Of Non Conforming Product
A
8.4 Analysis Of Data
A
8.5 ContinualImprovement, Corrective and Preventive Action
A
A – Authority, P – Primary, S – Secondary, C – Contributory, N – Not applicable.
Management Representative
Executive Management shall appoint a representative who, irrespective of other
responsibilities, shall have responsibility and authority that includes:
Ensuring that processes of the quality management system are established and
maintained;
Reporting to Executive Management on the performance of the quality
management system, including needs for improvement;
Promoting awareness of client requirements throughout the organization.
NOTE: The responsibility of these personnel may include liaison with external parties on
matters relating to the quality management system.
Methodology and Approach
A Management Representative is appointed within the Company and is identified as
having the responsibility for all operating procedures with the prefix QAP. This is in
addition to any other assigned duties and Quality System responsibilities.
The duties of the Management Representative are defined in the Job Descriptions
mentioned in the HR Policies and procedures.
Quality Manual Ver 1.0
Organization Chart
CHAIR PERSON
DIRECTOR MARKEITNG
DIRECTOR MARKEITNG
PRODUCTION MANAGER
ACCOUNTS MANAGER / MR
PURCHASE MANAGER
SUPERIVISORQUALITY CONTROL
SHOP FLOOR
Internal & External Communication
Department/Function Contact
Name
Designation Phone Mail ID
HR
Admin
Public Relations
Defense and Medical
Services
Trading and
Infrastructure Services
Quality Management
(MR)
Quality System Procedures
Internal Audit Procedure
The purpose of this section is to establish the purpose, authority, responsibility and
procedures for the Internal Audit Department.
Internal Auditing is an independent appraisal function established within an organization to
examine and evaluate its activities as a service to the organization. The objective of internal
auditing is to assist management and the Board in the effective discharge of their duties. It
is the Board's responsibility to set policies, and the auditor's role to independently and
objectively analyze, review, and evaluate existing procedures and activities, to report on
conditions, and to recommend changes for consideration. To this end, internal auditing
furnishes analyses, appraisals, recommendations, counsel, and information concerning the
activities reviewed.
Charges and responsibilities of internal audit:
1. Develop an audit plan to evaluate the institution's financial & operational
controls.
2. Assess the economical and efficient use of resources.
3. Determine the level of compliance with established laws, rules, policies and
procedures.
4. Recommend adoption of desirable policies or changes to existing policies.
5. Follow-up on the adequacy of corrective actions.
6. Conduct special projects at the request of the Board.
7. Investigate cases of misappropriation, misconduct, fraud.
8. Establish and maintain professional rapport with external auditors and
management.
9. Keep Audit Committee and Board fully informed on a timely basis of the
activities of the Internal Auditing Department.
10. Follow the Standards of the Professional Practice of Internal Auditing and Code
of Ethics as promulgated by the Institute of Internal Auditors.
Audit procedures
1. The Internal Auditor shall have unrestricted access to all records, personnel,
and equipment in carrying out the objectives of an audit.
2. All Board members have unrestricted access to the Internal Auditor. The
Internal Auditor has unrestricted access to all Board members. This promotes
independence.
3. The Internal Auditor shall develop an audit plan for review and approval by the
Audit committee. The audit plan shall be approved annually. The audit plan is
based on audit risk areas identified by Board members, top management,
external audit results, and internal auditor experience. The Internal Auditor will
develop audit objectives and scopes for each audit on the approved audit plan
for the president's review and the Audit Committee's review and approval. The
audit plan is sufficiently flexible to cover unanticipated demands on the Internal
Auditor given the changing college environment, e.g., unanticipated internal
audit areas may surface due to external audit results, or evidence of fraud may
surface that requires immediate Internal Auditor attention. The Audit Committee
shall review and approve a change in the audit plan.
4. The Internal Auditor shall notify the department being audited of the objective
and scope of the audit and the timetable for completion of the audit.
5. The Internal Auditor shall perform audits in accordance with generally accepted
auditing standards.
6. The Internal Auditor may perform different types of audits:
a. Full Audit - Normally, full audits are required when an area has never
been audited before, or significant changes have occurred subsequent to
the last audit. A full audit requires completion of all of the following
phases:
Preliminary Survey and Planning
System Documentation
Internal Control Evaluation
Audit Program
Audit Testing
Reports and Conferences
b. General Audit - A general audit usually does not require the completion of
all the phases of a full audit. The topics are usually conducted year after
year and tend to require the same testing. There is no need to fully
document the system and consider the impact of internal controls again -
it is only necessary to ensure that the system has not drastically changed
since the prior audit.
c. Spot Audit - A spot audit is a periodic audit of a particular transaction at a
particular point in time which gives reasonable assurance that controls in
place are still working. Results of spot audits may help determine if a full
audit should be scheduled. Examples are: an inventory location test, a
surprise cash count, or an unannounced payroll distribution.
d. Situational Audit - A situational audit is narrower in scope than a full audit.
It is usually an unanticipated project that may take priority over a planned
audit. The focus is usually based on a previously identified specific
control weakness, or the likelihood that a weakness not readily
identifiable exists. Examples are: a management or Board
requested special project, an integrity or fraud related issue.
e. Follow-up Audit - The focus of a follow-up audit is to contact the audited
department to determine if previously agreed to recommendations have
been implemented. The follow-up audit may require additional testing to
ensure that controls are working and effective as anticipated. An attempt
should be made to conduct a timely follow-up audit if a previous audit
uncovered serious control issues.
f. Opinion - An opinion may be required regarding a specific issue,
procedure, or task. It is part of Internal Audit's responsibilities to provide
counsel to management. Providing a professional opinion requires fact-
finding research such as reading authoritative texts, holding discussions
with key staff, and reviewing results of previous audits as applicable.
7. The Internal Auditor will communicate results of the audit. After the audit field
work is completed, the auditor will discuss the results with audited department
management. The Internal Auditor will prepare a draft (marked for discussion
purposes only) preliminary report to be shared with the audited department
management. After discussion and review with the audited department
management as to content and wording of the report, the preliminary report is
dated, signed by the Internal Auditor and issued to the department
management. The president shall receive a copy of the preliminary report. The
audited department has two weeks to respond to any recommendations or
comments contained in the preliminary report. The president can authorize an
extension of the response due date if unanticipated circumstances occur within
the audited department. The responses should explain the department's
corrective actions, the dates of implementation, or the reasons no corrective
action will be taken. The Internal Auditor shall determine the completeness and
propriety of the responses. If the responses are deemed not appropriate, the
Internal Auditor will meet with the audited department management to
recommend an alternative response. The president will receive a copy of the
final responses. The Internal Auditor will incorporate the final responses into the
preliminary report within two weeks of receipt of the responses. The final report,
which includes management's responses will be reviewed by the Audit Chair for
completeness. The final report will be dated, signed by the Internal Auditor and
issued to the Audit Committee and to the president. The audited department
management will receive a copy.
8. In some cases, a preliminary report is not necessary because the Internal
Auditor has no recommendations for the audited department management or no
response is necessary. In these cases, there is only a final report. The draft
final report will be discussed with the audited department management. After
discussion and review with the department as to content and wording of the
report, the Internal Auditor will forward the president a copy of the draft report.
The report will be reviewed by the Audit Chair for completeness. The report will
be dated, signed by the Internal Auditor and issued to the Audit Committee and
to the president. The audited department management will receive a copy.
9. Audit reports should be distributed to those who are able to ensure that audit
results are given due consideration.
Standards for the professional practice of internal auditing:
The following information is taken directly from the Standards for the Professional Practice of Internal Auditing published by the Institute of Internal Auditors. It is the internal auditor's responsibility to follow the standards. Standards are the criteria by which the operations of an internal auditing department are evaluated and measured. The procedures listed above should reflect the implementation of the standards. Independence:Internal auditors should be independent of the activities they audit. This isaccomplished through organizational status (the direct reporting relationship to the Board) and objectivity in performing audits.
Professional Proficiency: Internal audits should be performed with proficiency and
dueprofessional care. Internal auditors should comply with professional standards of
conduct; they should possess the knowledge, skills, and disciplines essential to the
performance of internal audits. Internal auditors should be skilled in dealing with
people and in communicating effectively; they should maintain their technical
competence through continuing education. Internal auditors should exercise due
professional care in performing audits. This calls for the application of the care and
skill expected of a reasonably prudent and competent internal auditor in the same or
similar circumstances; it implies reasonable care and competence, not infallibility or
extraordinary performance.
Scope of Work: The scope of the internal audit should encompass the examination
andevaluation of the adequacy and effectiveness of the organization's system of
internal control and the quality of performance in carrying out assigned
responsibilities. The objectives of internal control are:
1. The reliability and integrity of information. 2. Compliance with policies, plans, procedures, laws, and regulations. 3. The safeguarding of assets. 4. The economical and efficient use of resources. 5. The accomplishment of established objectives and goals for operations and
programs.
Performance of Audit Work: Audit work should include planning the audit, collecting,
analyzing, interpreting, and documenting information to support audit results,
communicating results, and following up to ascertain that appropriate action is taken
on reported audit findings.
Management of the Internal Audit Department: The Director of Internal Audit (i.e.,
Internal Auditor) should properly manage the department so that audit work fulfills its
approved general purposes and responsibilities and that the audit work conforms to
the Standards for the Professional Practice of Internal Auditing.
Control of Records and Documents
The purpose of this procedure is to outline the process for Document Control and Record
Management in accordance with QMS and other related system requirements.
This procedure describes the methodology for ensuring that the system documentation is
current and suitable for use. This includes the process to be followed for:
Document creation
Document review
Modification and update of documents (where necessary) that ensures the relevant competent personnel or parties are consulted and given a genuine opportunity to provide input prior to approval
Identification of documents to ensure the most current versions are identifiable, legible and available at points of use
The prevention of unintended use of obsolete documents
Document approval prior to issue
Communication of approved new or modified documents to relevant personnel.
Also described is the process for managing organizational records. Records shall be
maintained, archived and disposed of in accordance with system requirements,
customer/vendor agreements and legal/regulatory requirements.
Procedures
Document Review
Any controlled documentation requires regular review (at least every 3 years) to ensure
currency with internal/external requirements and continuous improvement in the provision of
an effective system to meet the business needs.
The review process includes consideration of the following:
Suitability and relevance to the workplace
Identified areas requiring improvement
Effectiveness in achieving desired outcomes, in particular where non-conformance or corrective action is required
Compliance with legislative requirements.
Obsolete Documents
Obsolete controlled documents are those which are no longer required, replaced or
superseded as determined by the needs of the system. Obsolete documents may be
identified as part of the review process and shall be removed from the system and
appropriately archived to prevent unintended use. Archived documents must be retained
and accessible for system evaluation and legal purposes.
Locally owned or developed QMS documentation identified as obsolete shall be removed
from points of issue by the workplace (appointed custodian), archived electronically (where
possible) or in hard copy and retained for system evaluation purposes and legal
requirements (where relevant).
Document Format
All QMS procedural documentation and associated forms or guidance notes are to use a
standard format. Workplaces are encouraged to review system documentation to ensure
relevance to their business and where necessary, make modifications to suit identified
needs whilst maintaining the standard format.
Exceptions to the standard document format outlined in this procedure include:
• Policy documents that are required to observe the Company Policy standard format; • Documentation in which QMS content is integrated and another standard format is
followed; • Any other material approved by the Management, ie. Newsletters, brochures, notes,
posters, etc.
The following standard format is applicable to all QMS procedures:
• Title • Purpose • Definitions • Roles and responsibilities • Procedural content • Performance measures (where applicable) • Documents/ Forms/Guidance Notes (where applicable) • References • Further Assistance (where applicable)
Draft documentation shall be easily identifiable by use of a ‘DRAFT’ watermark along with
identification of draft in the footer.
Document Approval Process
New or revised final draft documents are approved by the MR.
The MR will determine the need for referring final draft documents to the Senior
Management Group where there is potential for significant impact to business.
Once approved, the final controlled document is released and communication provided to
relevant personnel to allow implementation.
Minor changes, including grammar or spelling, are not deemed as content change and are
exempt from the approval process.
QMS Document Control Register
A master document control register shall be maintained for all system documentation
created or modified.
The Master Document Control Register will include the following:
• Document Title • Version Number • Date Created • Date Reviewed • Reasons/Comments for creation/review • Document Custodian
Corrective and Preventive Action Procedure
To ensure that corrective and preventive action is a vital closed loop system of root cause analysis, documented action, verification of effectiveness, and prevention of recurrence. This procedure applies to identified product, process, system nonconformities and problematic performance with respect to internal quality, service, customer complaints, work safety issues and discrepancies cited during internal audits and external audits at all facilities of the company.
Definition of Terms
Corrective / Preventive Action Notice (CAR Number): A unique number assigned to a
Corrective / Preventive Action Notice for easy identification and tracking purposes.
Corrective Action: Action taken to eliminate the root cause(s) and symptom(s) of an
existing undesirable deviation or nonconformity to prevent recurrence.
Nonconformity: A departure or deviation of a quality characteristic from its intended level or
state that occurs with severity sufficient to cause an associated product, process, system or
service not to meet a specified requirement.
Preventive Action: Action taken to eliminate potential nonconformance
Objective Evidence: Verifiable qualitative or quantitative information, observations, records
or statements of fact pertaining to the quality of the product, process or system.
Root-Cause:A fundamental deficiency that results in a nonconformance which must be
corrected to prevent recurrence of the same or similar nonconformance.
Responsibilities and Requirements
Quality Assurance
• Initiate and/or issue Corrective / Preventive Action Notice(s); • Review documented root cause and Corrective / Preventive Action Plan for approval; • Initiate follow-up verification (audit) of completed Corrective / Preventive Actions for
effectiveness; • File and maintain all Corrective / Preventive Action documentation. • Facilitate the preparation and implementation of Corrective/ Preventive Action Plans
Quality Auditors
• Perform follow-up verification of completed Corrective / Preventive Actions resulting from internal audits
Departmental Manager or Designee
• Participate in review or respond to Corrective / Preventive Action Notice(s) when requested;
• Investigate potential causes of nonconformance(s); • Assist in the development and implementation of a Corrective / Preventive Action
Plan.
Personnel
• Responsible for reporting problems and nonconformance to Quality Assurance on the Corrective/ Preventive Action Notice form.
Procedure
Preventive Action: Quality Assurance will determine the appropriate tools to detect,
analyze and eliminate potential causes of nonconformance. Use of Failure Mode and Effect
Analysis (FMEA), process mapping, Cause and Effect Diagrams and/or Statistical Process
Control may be applied to monitor the process. Information and/or data is collected to
determine areas needing preventive action.
Corrective Action: Both external and internal rejections of nonconformities require
root-cause analysis and corrective action. If the problem stems from a processing practice,
appropriate departmental personnel are contacted to initiate an investigation to determine
the root-cause of the nonconformance. After the root-cause of the nonconformance is
determined, corrective action is initiated to implement improved practices.
Corrective / Preventive Action may be requested as a result of:
• Internal and external audits; • Recall of product either voluntary or mandatory; • Review of product service records; • Feedback that identifies problematic performance with respect to
manufacturability of product or process operations; • Customer complaints due to dissatisfaction of products or services that may or
may not lead to the return of goods; • Review of NCMRS; • Product, process, or system nonconformance; • Other
Responsible Department Action
The department manager or designee that receives a Corrective/Preventive Action Notice
must implement immediate or special action (if noted on the Corrective/ Preventive Action
Notice form) in the time period specified. Upon receiving a Corrective/Preventive Action, the
recipient must perform the following:
Investigate the potential root-causes of the nonconformance;
Analyze suspect processes and/or operations to determine the specific root cause, then document on CAR form;
Develop, in conjunction with ISMF, a Corrective/Preventive Action Plan to eliminate the root cause and prevent its recurrence;
Document on the CAR form, sign and date the form. The plan must include a projected date of completion.
For a Corrective / Preventive Action Notice resulting from an internal quality audit, Internal
Audits, states the time period and method for responsible department action.
Corrective/Preventive Action Implementation
The responsible department manager implements the plan as prescribed by the projected
completion date.Changes in procedures and/or processes resulting from
Corrective/Preventive Actions are documented and recorded.Communication and training of
the changes, for affected individuals, are performed, documented and retained as Quality
Records.
When implementation is complete, the responsible department manager attaches or
references objective evidence of implementation on the Corrective / Preventive Action
Notice form, signs and dates the form, and sends the form to Quality Assurance.
Corrective / Preventive Action Follow-up Verification
Once implementation of Corrective / Preventive Actions are complete, Quality Assurance (or
Quality Auditor(s) for Corrective / Preventive Action resulting from an internal audit) performs
a follow up verification to assess and determine its effectiveness. Documented objective
evidence of effectiveness is required for closure and is attached to or referenced on the
Corrective / Preventive Action Notice form. If the Corrective / Preventive Actions are not
implemented in a timely manner, Quality Assurance will review the situation with the
department manager and establish a new priority. If the Corrective / Preventive Actions are
not effective, the responsible department is notified to develop a new action plan.
Once verification of effectiveness is complete, Quality Assurance or the Quality Auditor
signs and dates the Corrective / Preventive Action Notice form, and checks the CPAN
Closed checkbox. Quality Assurance updates the Corrective / Preventive Action Database,
notifies the originator and the responsible department that verification is complete, and files
the completed Corrective / Preventive Action form.
Flow Chart
Quality Assurance assigns CAR#, forwards CAR to responsible department
Responsible Department investigates, determines
root-cause of problem, develops action plan with
Quality Assurance to resolve problem
Responsible Department
executes action plan
Responsible Department takes
immediate or special action required
Review situation with Responsible Department and
establish new priority
Originator identifies and describes the problem or
potential problem on Corrective/ Preventive Action
Notice (CAR) form
QMS review: approve
Corrective/Preventive
action request?
Is immediate or special
action required?
QMS review: has action plan been completed by
projected completion date?
QMS follow-up verification: was solution
effective?
QMS documents reason for disapproval, notifies
originator and files request
-End-
QMS completes and files documentation.
-End-
Yes
Yes
No
No
Yes
Yes
No
No
Control of Non-conforming products or processes
The purpose of this procedure is to control all Non-conformances and their by preventing the same from
affecting the quality.
Procedure
All System related non-conformances raised during Internal Audits are recorded in CAR and
corrective action initiated as per Corrective Action Procedure.
All Non-conformances observed in the process shall be recorded via a CAR and appropriate
action shall be initiated.
All Non-conforming items are segregated and placed in identified Non-conforming area.
Non-conformance in the process
Non-conformances or deficiencies in any of the following Processes / operations / activities:
Procurement
Planning
Production
Quality Checks
Delivery
Vendor Verification
MR has to identify Nonconformance at subcontracted processes or during any of the processes
mentioned above and create a Corrective action request.Raise Non-conformity and inform stake
holders or relevant process owner.Identify Personnel responsible for the same and discuss the
various causes of Non Conformity.
Suitable on-the- job training to be provided where it is felt that such training can diminish non-
conformance.Take appropriate Correction / Corrective / Preventive Action and identify the
responsible person to take the action within the deadline specified.
The systems are subjected to Re inspection after fixes.
Follow-up
The MR shall follow-up against the action taken and scrutinize if the action taken has been implemented
by all necessary stakeholders.
Recommended